(90 days)
The Sharplan Model 5000 Alexandrite Laser System is intended for use in dermatology for the removal of dark, unwanted body hair.
The Sharplan Model Alexandrite Laser System is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation.
The provided text is a 510(k) summary for the Sharplan Model 5000 Alexandrite Laser System, indicating its clearance for marketing based on substantial equivalence to predicate devices for the removal of dark, unwanted body hair. While it mentions clinical data, it does not provide detailed acceptance criteria or a comprehensive study report in the format requested.
Therefore, much of the requested information cannot be definitively extracted from the provided text. However, I will answer what is available and indicate when information is not present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for device performance. It focuses on the device's substantial equivalence to predicate devices and its intended use for hair removal rather than specific metrics like success rate, adverse event rate thresholds, or hair reduction percentages.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Clinical data on 40 subjects was presented." |
| Not specified | "intended for use in dermatology for the removal of dark, unwanted body hair." |
| Not specified | "From both a design and clinical perspective, the predicate and candidate devices, are of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Sharplan Lasers, Inc. believes that no significant differences exist. Therefore, the Sharplan Model 5000 Alexandrite Surgical Laser should not raise any concerns regarding its overall safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: 40 subjects
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The nature of "clinical data on 40 subjects" for hair removal would typically involve physician assessment, but no details about the number or qualifications of these experts are given.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not relevant to this device, which is an Alexandrite Laser System for hair removal, not an AI-assisted diagnostic tool involving human readers. Therefore, no such study was done, and no effect size for human readers with/without AI assistance is applicable or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a laser system, not an algorithm. Its performance is inherent to the device's operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a hair removal device, the "ground truth" would likely be the observed outcome of hair reduction or removal, assessed visually or through other objective measures (e.g., hair count in a defined area). The document only states "Clinical data on 40 subjects was presented," implying that patient outcomes after treatment were evaluated.
8. The sample size for the training set
This information is not provided. The term "training set" is generally used for machine learning models, which is not applicable here. The "clinical data on 40 subjects" likely refers to the pivotal clinical evidence presented for the device, not a training set in the AI sense.
9. How the ground truth for the training set was established
As the concept of a "training set" in the context of AI/machine learning is not applicable here, this information is not provided. If referring to how the "clinical data on 40 subjects" established efficacy, it would be through direct observation of hair removal/reduction results post-treatment, likely by a clinician, but the methodology is not detailed.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.